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Trial record 1 of 1 for:    NCT02167971
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Brain Stimulation for Traumatic Brain Injury (TMS/DAI)

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ClinicalTrials.gov Identifier: NCT02167971
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Iuri Santana Neville Ribeiro, University of Sao Paulo

Brief Summary:
The purpose of this study is to determine whether repetitive Transcranial Magnetic Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse axonal injury(DAI) after Traumatic Brain Injury(TBI).

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Diffuse Axonal Injury Other: Active Coil Other: Sham Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Repetitive Transcranial Magnetic Stimulation on the Cognitive Rehabilitation After Traumatic Diffuse Axonal Injury.
Actual Study Start Date : January 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Coil
The patients assigned to this group will undergo repetitive Transcranial Magnetic Stimulation over 10 sessions (each one with 2,000 pulses) on left dorsolateral prefrontal cortex.
Other: Active Coil
The patients will undergo 10 sessions (2,000 pulses each, lasting 20 minutes) of repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex with the following parameters: 10Hz, 50 trains (40 pulses on each train), biphasic wave, 25 seconds between the trains.

Sham Comparator: Sham
The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.
Other: Sham
The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.




Primary Outcome Measures :
  1. Evidence of improvement on Attentional processes measured by cognitive evaluation (Trail Making Test parts A and B; Stroop Test - Victoria Version; Symbol Digit Test) [ Time Frame: One week and three months after rTMS. ]

Secondary Outcome Measures :
  1. Evidence of improvement on Executive Function processes measured by cognitive evaluation. [ Time Frame: one week and 3 months. ]
  2. Evidence of improvement on Motor Coordination measured by cognitive evaluation. [ Time Frame: one week and three months. ]
  3. Changes in cortical excitability measured by single and paired-pulse TMS [ Time Frame: one week and three months. ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical and radiological diagnosis of traumatic brain injury.
  • Between one to two years after traumatic brain injuri
  • Must be able to sign the Informed Consent Form

Exclusion Criteria:

  • Drug addiction
  • Uncontrolled epilepsy
  • Extensive Cranial vault defects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167971


Locations
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Brazil
Clinics Hospital - University of Sao Paulo Medical School
Sao Paulo, SP, Brazil, 054010-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Study Chair: Wellingson S Paiva, MD University of Sao Paulo
Principal Investigator: Iuri N Ribeiro, MD University of Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Iuri Santana Neville Ribeiro, iurineville, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02167971     History of Changes
Other Study ID Numbers: USP-01
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017

Keywords provided by Iuri Santana Neville Ribeiro, University of Sao Paulo:
traumatic brain injury
diffuse axonal injury
repetitive transcranial magnetic stimulation
neuromodulation
cognitive rehabilitation

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Diffuse Axonal Injury
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Injuries, Diffuse